# A behaviour change intervention promoting physical activity following dysvascular amputation: Protocol for a pilot study

## TL;DR

This pilot study tests a peer-led physical activity intervention to improve health and quality of life for people who have had a lower limb amputation due to diabetes.

## Contribution

The study introduces a novel peer-led physical activity intervention for individuals with dysvascular lower limb amputation.

## Key findings

- The pilot study will assess the feasibility of a peer-led physical activity intervention for people with lower limb amputation.
- Primary outcomes will include physical activity levels and self-efficacy, measured using wearable monitors and self-report scales.
- Qualitative interviews will explore the acceptability and feasibility of the intervention from participants and peer coaches.

## Abstract

Diabetes-related lower limb amputation (LLA) is a leading cause of disability globally, impacting individuals’ physical and mental health, and ultimately their quality of life. Physical activity can reduce risk of chronic disease and mortality while improving quality of life. However, people with LLA often have reduced balance and walking ability resulting in sedentary behaviour. We co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support physical activity behaviour change in people with dysvasular LLA. To date, no studies have assessed a peer-led physical activity behaviour change intervention for people with LLA. Prior to launching a large trial, a pilot study is required to assess feasibility and optimize design of a future trial.

This pilot study is a parallel group randomized controlled trial (RCT) with an embedded qualitative component. The intervention group will have access to once-weekly virtual peer coaching sessions with a peer trained in brief action planning; web-based physical activity modules; and a wearable activity monitor for 8 weeks. The control group will continue usual care and be offered the intervention at the end of the follow-up period. Data on feasibility will be collected including assessment of process, resource, management and treatment indicators. The proposed primary outcomes will be measured at baseline, post-intervention and one month later: total physical activity counts per day measured by the ActiGraphTM activity monitor and self-efficacy measured by the Self-efficacy for Exercise scale. Secondary measures include patient reported outcome measures of physical activity, mobility, depression, social participation, balance confidence and quality of life. Semi-structured interviews will explore feasibility and acceptability of the intervention to participants and peers.

This study will inform the design of a definitive RCT to determine the effectiveness of a peer-led physical activity intervention for people with dysvascular LLA.